1. Changing Smoking Habits

2. Politics of Tobacco Regulation
FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S. 2000)

3. Pharmacology of Tobacco
Primary drug effect is nicotine
Strong nervous system drug using in classic neurophysiology research
Great natural bug killer
An oily plant that makes a smoky fire
Tars from combustion cause cancer and emphysema
Is marijuana safer?

4. Public Health Impact of Tobacco
#1 preventable cause of illness
#1 problem is heart disease
6 out of 7 smokers do not live to get lung cancer
Heart attack data on secondary smoking
Emphysema is the big lung issue - nasty way to live, then you die
Poorly understood genetic factors affect individual risk.
Less risk for smokers in Japan – could diet matter?

5. Second Hand Smoke Children of smokers More respiratory problems
More likely to smoke
Workplaces and homes
Reduction in heart attacks after smoking bans
This was unexpected – significant and quick decline after bans

6. In Defense of Tobacco
Tobacco will reduce life-time health care costs if you smoke enough
Ideally you will also eat a lot of burgers while sitting on the couch watching TV
Limits retirement costs
Saves Medicare and Social Security
Great for private pension plans as well
Also improves job opportunities for young, cheaper workers

7. Problems in Stopping Smoking
“Giving up smoking is the easiest thing in the world. I know because I've done it thousands of times.”
― Mark Twain
Easier to quit heroin
Why?
What about Starbucks?

8. The Surgeon General’s Report - 1964
First official notice of risks of tobacco
Began a long term decline in smoking
With some exceptions, smoking moves from the wealthy and middle class to the poor and poorly educated.
May have plateaued after the tobacco settlement
States make more money if kids smoke.

9. Reducing Smoking The price Taxing the poor? Smoking limitations
Reduce the amount smoked
Even LA banned indoor smoking
Insurance surcharges?
This is now being done
Why not ban tobacco?
How has that worked out with heroin?

10. Regulatory History of Tobacco

11. Economic History of Tobacco
What was the role of tobacco in the colonial period?
What are the economics of tobacco?
Why has CVS banned tobacco?
What is the primary role of the Bureau of Alcohol Firearms and Tobacco?
What happened when Canada raised tobacco taxes?

12. Federal Cigarette Labeling and Advertising Act - 1965/1969
Required hazard labeling on cigarettes
Banned cigarette advertising in electronic media regulated by the FCC
Why not ban it everywhere?
Prevented additional state requirements
Which requirements were they worried about?
What happened in torts in 1965?
What about non-tort concerns?

13. History of the FDA

16. FDA Jurisdiction Based on interstate sale of the drug/device
Not the broad definition of interstate commerce used in civil rights cases
Only regulates manufacturing, interstate sale, and promotion.
No authority over how drugs are prescribed and used
State regulation and state criminal law
Drug Enforcement Administration
Unless there is a state FDA, you can make and sell a drug within a state and not be under FDA regulation

17. Shared Federal Jurisdiction
BAFT – Bureau of alcohol, tobacco, and firearms
BATF deals with tax issues of tobacco
DEA – Drug Enforcement Agency
Federal limits on the prescribing and use of drugs through the Controlled Substances Act
Administrative regulation of medical prescribing and sale, with a criminal law focus.
Pure criminal law enforcement of non-medical sales and use.

18. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (U.S. 2000)
What had the FDA said about it authority to regulate regulation over the past 50 years?
Which group of smokers did the regulation target?
Why this group?
How did the regulation attempt to reduce smoking in this group?
What was the tobacco companies attack on this regulation?

19. What Does the Statute Say?
Chevron Step One
What Does the Statute Say?

20. Definition of Drugs
The Act defines "drug" to include "articles (other than food) intended to affect the structure or any function of the body." 21 U. S. C. §321(g)(1)(C).

21. Definition of Devices
It defines "device," in part, as "an instrument, apparatus, implement, machine, contrivance, ... or other similar or related article, including any component, part, or accessory, which is ... intended to affect the structure or any function of the body." §321(h).

22. Definition of Combination Products
The Act also grants the FDA the authority to regulate so-called "combination products," which "constitute a combination of a drug, device, or biologic product." §353(g)(1). The FDA has construed this provision as giving it the discretion to regulate combination products as drugs, as devices, or as both. See 61 Fed. Reg (1996).

23. Tobacco as a Combination Product
Is tobacco a drug under the statutory definition?
What constituent is clearly a drug?
Is a cigarette a combination product?
What is the purpose of a cigarette?
Does this meet the definition of a device?
How would e-cigarettes fit into this scheme?

24. Chevron - Step One Does tobacco fall under the statute?
Is it specifically named?
Does it effect the structure or function of the body?
Is it sold for its effects on the body?
Is it specifically prohibited?
Is the language of the statute ambiguous?

25. Would Regulating Tobacco under the FDA Lead to Results not Intended by Congress?

26. What Information is on Cigarette Labels?

27. Adulteration and Misbranding
The Act prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adultered or misbranded." 21 U. S. C. §331(a)
§352(j) deems a drug or device misbranded "[i]f it is dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.”
Is tobacco misbranded under §352(j)?
Why?

28. Labeling Requirements
Second, a drug or device is misbranded under the Act "[u]nless its labeling bears ... adequate directions for use ... in such manner and form, as are necessary for the protection of users," except where such directions are "not necessary for the protection of the public health." §352(f)(1).
Difference between prescription and over the counter (OTC) drugs.
Can tobacco be labeled to comply with this section?

29. Does the FDA Model fit Tobacco?
Does tobacco fit within the definition of a drug?
Is tobacco safe and effective for any use?
Is it possible to label tobacco so it can be used safely?
What would be the effect of applying the safe and effective test to tobacco?

30. Regulating, not Banning Tobacco
How does the FDA argue that it does not have to show that tobacco is safe and effective?
What are the arguments against banning tobacco?
How can regulation make tobacco safer, if not safe?
Is safer OK under the “safe for the intended use” test?
How is tobacco different from chemotherapy drugs?

31. What are Other Factors Indicating that Congress did not Intend for the FDA to Regulate Tobacco?
Are there other agencies that regulate tobacco?
Has Congress considered regulating tobacco, but not done some when amending the FDA?
What are the economic regulatory issues with tobacco?
Is tobacco taxed?
Is it a major commerce item?
How would these be affected if the FDA were have to ban tobacco?

32. MCI Telecommunications Corp. v. American Telephone & Telegraph Co
MCI Telecommunications Corp. v. American Telephone & Telegraph Co., 512 U. S. 218 (1994)
“The FCC contended that, because the Act gave it the discretion to "modify any requirement" imposed under the statute, it therefore possessed the authority to render voluntary the otherwise mandatory requirement that long distance carriers file their rates.”
Why should the Court find this problematic?

33. United States Supreme Court Opinion
“Reading the FDCA as a whole, as well as in conjunction with Congress' subsequent tobacco-specific legislation, it is plain that Congress has not given the FDA the authority that it seeks to exercise here. For these reasons, the judgment of the Court of Appeals for the Fourth Circuit is affirmed.”
Does this now relate back and change Step 1, i.e., is this the Chevron Step 0?

34. The Politics
The majority (including Scalia) said this was evidence that Congress did not intend for the FDA to regulate tobacco, and that such intent trumped Chevron
Minority (Breyer) said just look at the law
Politics trumps principle (which is probably right in this case)
Congress later gave the FDA some authority over tobacco.

35. E-Cigarettes and Vaping
Advantages
No smoke with tars, etc.
No second hand smoke
Questions
How would you analyze vaping under the law as it existed at the time when B&W was decided?